Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer

Not Applicable

• Conditions: Low Rectal Cancer
• Interventions: Procedure: Transanal minimally invasive total mesorectal excision; Procedure: transanal minimally invasive locoregional resection

• Registration Number: NCT02488577
• Lead Sponsor: Osama Mohammad Ali ElDamshety

Brief Summary

Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12
• Primary Completion: 2019-06
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• T2 N0 low rectal cancer

Exclusion Criteria

• patients unfit for laparoscopic resection
• Unwilling to share in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TAMIS TME	Transanal minimally invasive total mesorectal excision	T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.
TAMIS-Local	transanal minimally invasive locoregional resection	T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.

Primary Outcome Measures

Name	Time	Method
Overall percent of postoperative complications.	30 days	the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.

Secondary Outcome Measures

Name	Time	Method
Recurrence.	2 years	number of local and distant recurrence
Hospital stay	30 days	Number of Days starting from the admission till discharge